Publication Date

2020

Abstract

The Food and Drug Administration's citizen petition process provides an avenue for ordinary citizens to raise concerns and participate in the regulatory process. Abuse of that process has been documented as an example of the legal maneuvering used by pharmaceutical companies to protect their brand-name drug revenue streams from the introduction of low-cost generics. To date, the financial cost to society of these delays has not been calculated in the literature, which likely hinders the push for policy solutions. Drawing from a previously published data set on 249 citizen petitions, this Article will identify four petitions that were highly likely to have been the final obstacle to a generic drug entering the market. Specifically, the petitions were denied; the FDA approved the generics within one business day of denying the petitions; and the generics came to market within one week of the FDA's approval, signaling that the petitions were the final obstacle standing in the way of the generic's entry to market. Using these four dubious citizen petitions, this Article will find that the total financial cost to society from citizen petition delays was $1.9 billion or $3.6 million per day.' The total financial cost to government-provided insurance programs in the same period was roughly $782 million. This Article will employ a conservative methodology (choosing only four petitions that meet the criteria of "but for" this citizen petition, the generic would have gone to market). Thus, the estimates are likely low. Citizen petitions that contributed to a generic delay as one of many tactics or for which there was not sufficient volume and usage information were eliminated from consideration in this estimate.

Document Type

Article

Publication Title

Maryland Law Review Online

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